Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Patients With Multiple Fracture Ribs

NCT ID: NCT03853330

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-12-30

Brief Summary

To assess the analgesic and respiratory effect of continuous Erector Spinae Plane block versus Thoracic Epidural in patients with multiple fracture ribs.

Detailed Description

Erector spinae plane (ESP) block is a recently described technique which may be an alternative to Paravertebral block (PVB) for providing thoracic analgesia. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. ESP is a more superficial block with a better defined end-point injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. ESP does not have the same risk of pneumothorax as PVB.

Epidural analgesia has become the standard of care. Although thoracic epidurals provide excellent analgesia for the management of rib fractures, they are limited to a certain population due to patient factors and side-effects. Many trauma patients have other injuries which contraindicate the use of epidurals, or which prevent positioning for insertion. There are disadvantages to thoracic epidural analgesia. They are technically challenging to insert, with a risk of dural puncture or spinal cord injury. Adverse effects include hypotension, and if opioids used, urinary retention and pruritus. Patients can develop a motor block and are unable to mobilize with an epidural in situ.

Conditions

Fracture; Rib, Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Thoracic Epidural Analgesia group

25 patients will receive ultrasound-guided thoracic epidural analgesia for multiple fracture ribs at the level of T8 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used.

Group Type: ACTIVE_COMPARATOR

Ultrasound

Intervention Type: DEVICE

Ultrasound-guided Thoracic Epidural Analgesia and Erector spinae plane block.

Bupivacaine HCl Inj 0.25%

Intervention Type: DRUG

Bupivacaine HCl Inj 0.25% will be used in both blocks by the same dose of 7.5-12 ml

Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution

Intervention Type: DRUG

infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h will be used in both blocks and also for breakthrough pain after both blocks as a bolus of 5-10 ml.

Erector spinae plane block group

25 patients will receive ultrasound-guided ESP block for multiple fracture ribs at the level from T1 to T5 with 7.5-12 ml of Bupivacaine HCl Inj 0.25% as a loading dose followed by catheter insertion and infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h. For breakthrough pain bolus of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution 5-10 ml can be used.

Group Type: ACTIVE_COMPARATOR

Ultrasound

Intervention Type: DEVICE

Ultrasound-guided Thoracic Epidural Analgesia and Erector spinae plane block.

Bupivacaine HCl Inj 0.25%

Intervention Type: DRUG

Bupivacaine HCl Inj 0.25% will be used in both blocks by the same dose of 7.5-12 ml

Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution

Intervention Type: DRUG

infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h will be used in both blocks and also for breakthrough pain after both blocks as a bolus of 5-10 ml.

Interventions

Ultrasound

Ultrasound-guided Thoracic Epidural Analgesia and Erector spinae plane block.

Intervention Type: DEVICE

Bupivacaine HCl Inj 0.25%

Bupivacaine HCl Inj 0.25% will be used in both blocks by the same dose of 7.5-12 ml

Intervention Type: DRUG

Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution

infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h will be used in both blocks and also for breakthrough pain after both blocks as a bolus of 5-10 ml.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with multiple fracture ribs.

Exclusion Criteria

• Patient refusal.
• Patients with pre-existing infection at the block site.
• Coagulopathy.
• Allergy to local anesthetics.
• Pre-existing neurological deficits.
• Psychiatric illness.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Rasha Hamed

Ass. Prof. in Anesthesia and ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University Hospital

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Analgesia for Fracture Ribs

Identifier Type: -

Identifier Source: org_study_id